Poster
136
(#136) Viloxazine ER for Adults with Attention-Deficit/Hyperactivity Disorder and Mood Symptoms: Results of a Decentralized, Open-label, Phase IV Trial
Psych Congress 2025
Abstract: Introduction: Viloxazine ER is an FDA-approved medication for pediatric and adult ADHD. Adult ADHD is often associated with psychiatric comorbidities. Here we present results of a decentralized, open-label, phase IV trial [NCT06185985] evaluating viloxazine ER in adults with ADHD and comorbid mood symptoms.
Methods: Participants (primarily recruited via social media) had a primary diagnosis of ADHD, an ADHD Investigator Symptom Rating Scale (AISRS) score ≥24, Clinical Global Impression of Severity (CGI-S) for ADHD score ≥3, and MADRS and/or HAM-A scores >22. Viloxazine ER (200-600 mg/day) was added to patients' existing medications for 14 weeks. Clinician-Rated Outcomes (e.g., AISRS [primary], MADRS, HAM-A, and CGI-S/C) were assessed at televisits. Patient-Reported Outcomes (e.g. ASRSv1.1-SC, PHQ-8, GAD-7) were assessed using mobile app. Safety measures included adverse events, suicidality, blood pressure, weight and pulse rate.
Results: Treated participants (N=161, 39.4 yrs, 75.8% female) had clinically relevant ADHD (mean±SD AISRS: 37.5±6.6), depression (MADRS: 30.3±3.1) and anxiety (HAM-A: 25.5±2.4) symptoms at Baseline; 99.4% had both MADRS and HAM-A >22. ADHD, depression and anxiety symptoms all showed significant improvement by end of study (AISRS: -17.3±11.3, MADRS: 15.5±7.1, and HAM-A: -14.2±5.8, P.0001 for all, one sample t-test). Patient-ratings showed similar improvements. Common AEs included (≥5%) nausea, insomnia, constipation, headache, fatigue, somnolence, decreased appetite, dry mouth, and migraine and were typically mild or moderate in severity. AEs led to discontinuation of study drug in 14.9%.
Conclusions: Adults treated with viloxazine ER alone or added to existing treatments, experienced improvement in ADHD, depression, and anxiety symptoms with acceptable safety and tolerability.
Short Description: Viloxazine ER is an FDA-approved medication for pediatric and adult ADHD. Adult ADHD is often associated with psychiatric comorbidities. Here we present results of a decentralized, open-label, phase IV trial [NCT06185985] evaluating viloxazine ER in adults with ADHD and comorbid mood symptoms.
Name of Sponsoring Organization(s): Supernus Pharmaceuticals, Inc.
Methods: Participants (primarily recruited via social media) had a primary diagnosis of ADHD, an ADHD Investigator Symptom Rating Scale (AISRS) score ≥24, Clinical Global Impression of Severity (CGI-S) for ADHD score ≥3, and MADRS and/or HAM-A scores >22. Viloxazine ER (200-600 mg/day) was added to patients' existing medications for 14 weeks. Clinician-Rated Outcomes (e.g., AISRS [primary], MADRS, HAM-A, and CGI-S/C) were assessed at televisits. Patient-Reported Outcomes (e.g. ASRSv1.1-SC, PHQ-8, GAD-7) were assessed using mobile app. Safety measures included adverse events, suicidality, blood pressure, weight and pulse rate.
Results: Treated participants (N=161, 39.4 yrs, 75.8% female) had clinically relevant ADHD (mean±SD AISRS: 37.5±6.6), depression (MADRS: 30.3±3.1) and anxiety (HAM-A: 25.5±2.4) symptoms at Baseline; 99.4% had both MADRS and HAM-A >22. ADHD, depression and anxiety symptoms all showed significant improvement by end of study (AISRS: -17.3±11.3, MADRS: 15.5±7.1, and HAM-A: -14.2±5.8, P.0001 for all, one sample t-test). Patient-ratings showed similar improvements. Common AEs included (≥5%) nausea, insomnia, constipation, headache, fatigue, somnolence, decreased appetite, dry mouth, and migraine and were typically mild or moderate in severity. AEs led to discontinuation of study drug in 14.9%.
Conclusions: Adults treated with viloxazine ER alone or added to existing treatments, experienced improvement in ADHD, depression, and anxiety symptoms with acceptable safety and tolerability.
Short Description: Viloxazine ER is an FDA-approved medication for pediatric and adult ADHD. Adult ADHD is often associated with psychiatric comorbidities. Here we present results of a decentralized, open-label, phase IV trial [NCT06185985] evaluating viloxazine ER in adults with ADHD and comorbid mood symptoms.
Name of Sponsoring Organization(s): Supernus Pharmaceuticals, Inc.
